Phase Ia/Ib Study of CKD-512 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Solid Tumors

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumors, Metastatic Solid Tumors

In brief

The purpose of this first-in-human (FiH) study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of CKD-512 given alone and in combination with pembrolizumab in subjects with advanced or metastatic solid tumors who have failed all standard available therapy.

Key facts

Study ID

NCT07215637

Run by

Chong Kun Dang Pharmaceutical

People needed

60

Starts

2025-10-16

Expected to finish

2027-09-01

Last updated by the study team

2026-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed advanced or metastatic solid tumors.
• Progressive disease after or intolerance to standard therapy and no other effective therapeutic options available.
• Measurable disease as defined in Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Suitable venous access for the study-required blood sampling, including PK and PD sampling.
• Adequate clinical laboratory values and other measures

You may not qualify if…

• Active disease involvement of the central nervous system.
• Any serious or life-threatening medical condition unrelated to cancer, psychiatric illness, drug or alcohol abuse, that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
• Systemic anticancer treatment within the protocol-specified period prior to the first dose.
• History of any immune-related toxicity that lead to permanent discontinuation of prior anticancer therapy
• Radiation therapy on a limited area is allowed until 4 weeks prior to the first dose of study drug, provided that the radiated lesion is clinically stable.
• Prior treatment with investigational agents ≤21 days before the first dose of study drug(s).

Where it is running

• Severance Hospital, Yonsei University Health System — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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